CompletedNot Applicable

Pilot Study of Vagal Stimulation in Chronic Low Back Pain

France30 participantsStarted 2023-02-15

Plain-language summary

Low back pain is a major public health problem. It is the leading cause of disability in the world. The factors that lead to chronicity of low back pain are multi-factorial and are essentially represented by psychosocial factors (catastrophism, kinesiophobia, algophobia job dissatisfaction, emotional problems such as depression, anxiety, stress, injustice, etc.). Pain is a multimodal experience that involves different brain structures that are activated by the pain signal and involve the autonomic nervous system (ANS). The vagus nerve is the main actor of one of the two branches of the ANS, the parasympathetic system, which acts as a "slow-down". The vagus nerve participates in the inter-neuronal transmission of key neurotransmitters for mood, alertness, attention and motivation. Vagal stimulation has been used for many years as an analgesic device in chronic pain (vascular pain (facial vascular pain, fibromyalgia, visceral pain, gastrointestinal and pelvic pain...) To date, no study has been conducted on the value of vagal stimulation in chronic low back pain.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Low back pain with a VAS greater than or equal to 40 that has been ongoing for more than 3 months * Failed or insufficiently relieved by private physiotherapy * Failed or insufficiently relieved or intolerant of level II analgesics * No change in therapy envisaged within one month. Exclusion Criteria: * Non-common low back pain will not be accepted (presence of red flags). * Auricular canal not adapted to the stimulation device. * Use of another type of electrical device (pacemaker or TENS). * History of vagotomy. * Heart rhythm disorder. * Presence of a cochlear implant on the stimulation side * Pregnancy in progress or planned during the study period * Adult protected by law or patient under guardianship or curator * Person unable to give consent. * Participation in other ongoing biomedical research * Absence of express informed consent after a reflection period * Not being affiliated to a French social security system or being a beneficiary of such a system

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used vagal stimulation for chronic low back pain and has already been completed — would it be worth asking if the results have been published, and what the data showed about changes in pain at the one-month mark?
2Since this was listed as a pilot study with no formal phase designation, what does that mean for how much is known about the safety and effectiveness of vagal stimulation compared to more established treatments for my back pain?
3The trial only measured pain change over one month — is that long enough to tell us anything meaningful about whether vagal stimulation could help me in the longer term, or would I need more evidence before considering this approach?
4Given that this study is now completed, are there any follow-up or larger trials on vagal stimulation for low back pain that might be recruiting, and would I potentially be a candidate worth discussing with you?
5Before exploring experimental approaches like vagal stimulation, are there standard treatments for chronic low back pain that I haven't tried yet that might be a better starting point given my specific situation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change from baseline pain at 1 month

Timeframe: between baseline and 1 month

Trial details

NCT IDNCT05639270

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-14

View on ClinicalTrials.gov More Low Back Pain trials